Frequently Asked Questions

What is heart failure?
What are the signs and symptoms of heart failure?
What is HeartNet™ and how does it work?
What is the clinical research study?
How do I know if I am eligible to participate in the PEERLESS-HF clinical research study?
Are there any costs for participating in the PEERLESS-HF clinical research trial?
What are the requirements for potential participants?

What is heart failure?

Heart failure (also called congestive heart failure, HF or CHF) occurs when the heart is no longer able to pump blood efficiently to the vital organs and throughout the body. Because of disease or injury to the heart, the primary pumping chamber of the heart (the left ventricle) can’t provide enough oxygenated blood to the body. As the body tries to compensate for the decreased blood flow, the heart increases in size, making it even less efficient. As part of this process, fluid “backs up” or accumulates in body tissues, further increasing the load on the heart.

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What are the signs and symptoms of heart failure?

The symptom most commonly reported is constant fatigue, followed by shortness of breath. Other problems associated with heart failure are edema (swelling), most often in the legs. Cough, weight gain as a result of fluid retention, chest pain and acute pulmonary edema are often present as well.

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What is HeartNet™ and how does it work?

HeartNet is an investigational device that is placed permanently around the heart in an in-patient, surgical procedure that typically takes less than 90 minutes to complete. The device itself is made of an elastic mesh. The intent of HeartNet is to gently reinforce the walls of the heart to slow or stop the enlargement process, thereby allowing the heart to work more efficiently.

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What is the clinical research study?

The PEERLESS-HF clinical research study is designed to determine the safety and effectiveness of HeartNet therapy compared to the current standard of care. All clinical research studies follow a medical protocol and conform to the United States government’s Food and Drug Administration (FDA) regulations. Additionally, every clinical trial in the U.S. must be reviewed and approved by an Institutional Review Board (IRB), whose job it is to protect the rights and safety of those who volunteer to take part in research studies.

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How do I know if I am eligible to participate in the PEERLESS-HF clinical research study?

You must first meet the initial screening eligibility criteria. Once you have met those criteria and have provided permission to forward your contact information to the research site in your area, you will need to have some additional testing. At that point, your eligibility will be determined by the medical professionals at your study site.

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Are there any costs for participating in the PEERLESS-HF clinical research trial?

Participation in this research study is on a volunteer basis and does not involve any direct cost to you. Your medical insurance carrier will be expected to pay for the therapy and the follow-up requirements, as permitted. Those costs related to the study that are not covered by insurance will be covered by the study sponsor, Paracor Medical.

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What are the requirements for potential participants?

• Participants must sign an informed consent. An informed consent means that a participant gets the key facts about the clinical research study so that they can decide whether or not they wish to participate. Informed consent is not a contract. Participants can choose to withdraw from this clinical research study at any time.
• All participants will undergo tests to make sure they qualify for the clinical research study. This is called “screening.” In addition to a medical history and physical exam, several tests (including things such as blood tests, a six-minute walk test and a pulmonary function test, among others) would be required. None of the testing is considered to be invasive.
• If qualified for enrollment in the trial, participants will be randomized to either the Treatment Group or the Control Group. Patients enrolled in the Treatment Group will receive a HeartNet implant and continue to receive optimal medical and device therapy. Those enrolled in the Control Group will NOT receive an implant, but will continue to receive optimal medical and device therapy under the care of a heart failure specialist associated with this study.
• After enrollment in the study, you will be scheduled for office visits at three months, six months, one year, and every twelve months thereafter for five years.

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